Zoetis Inc. is hiring an Associate – Regulatory Affairs (Off Role) in Mumbai, India. This opportunity is ideal for B.Pharm or M.Pharm professionals with 3–4 years of experience in pharmaceutical drug registration, regulatory submissions, and compliance management.
The selected candidate will support regulatory operations across India, Sri Lanka, Nepal, and Bangladesh, focusing on veterinary drug, medical device, and vaccine registrations while ensuring compliance with Drugs and Cosmetics regulations and Department of Animal Husbandry guidelines.
Professionals with experience in SUGAM portal submissions, import license documentation, regulatory liaison coordination, and affiliate quality management are strongly encouraged to apply.
Job Overview
- Position: Associate – Regulatory Affairs (Off Role)
- Company: Zoetis Inc. India Ltd
- Location: Mumbai, Maharashtra, India
- Experience: 3–4 Years
- Qualification: B.Pharm / M.Pharm or related pharmaceutical background
- Industry: Pharmaceutical & Life Sciences
- Department: Legal & Regulatory Affairs
- Employment Type: Full-time
Key Responsibilities
Regulatory Affairs Management
- Manage veterinary drug, vaccine, and medical device registrations according to Drugs & Cosmetics regulatory requirements.
- Coordinate with manufacturing sites for New Drug Application (NDA), registration certificates, and regulatory query responses.
- Prepare and maintain regulatory documentation for product approvals and variations.
- Ensure product dossiers comply with local regulatory guidelines and corporate policies.
- Work closely with regulatory liaison agents to ensure smooth submission and approval processes.
- Perform regulatory submissions through SUGAM and NSWS portals.
- Maintain site registration records and import license databases.
- Coordinate packaging updates and regulatory changes with cross-functional teams.
- Communicate and collaborate with local FDA authorities and regulatory bodies.
Affiliate Quality Support
- Assist affiliate quality teams regarding logistics service provider compliance.
- Address quality queries and product complaints.
- Maintain regulatory and quality compliance data for affiliate operations.
Required Qualifications
Education
- B.Pharm or M.Pharm in Pharmacy or related pharmaceutical discipline.
Experience
- 3–4 years of experience in pharmaceutical drug registration or regulatory affairs.
- Experience in medical device registration, quality assurance, or pharmacovigilance is an advantage.
Skills
- Knowledge of Indian regulatory procedures and legal requirements.
- Hands-on experience with SUGAM regulatory portal submissions.
- Familiarity with Department of Animal Husbandry and Dairying filing procedures.
- Strong communication and interpersonal skills.
- Proficiency in MS Office (Excel, Word, PowerPoint).
- Ability to analyze regulatory issues and propose effective solutions.
Why Join Zoetis India?
Working with Zoetis India provides professionals the opportunity to contribute to animal health innovation and global pharmaceutical regulatory operations.
Key advantages include:
- Exposure to multi-country regulatory environments (India, Sri Lanka, Nepal, Bangladesh).
- Opportunity to work on veterinary pharmaceuticals, vaccines, and medical devices.
- Experience with regulatory filings, compliance management, and global quality standards.
- Career development in regulatory affairs and pharmaceutical compliance.
How to Apply
